Senior Scientist, Device Engineering - Boston
1 month ago
Job summary
We are seeking an experienced Senior Scientist Device Engineering to lead the development and launch of drug-device combination products with a strong emphasis on autoinjectors pre-filled syringes and multidose pens. This role will drive cross-functional collaboration across CMC quality regulatory manufacturing clinical and commercial teams to ensure robust product development aligned with global standards and regulatory expectations.Lead the design and development of combination products including autoinjectors pre-filled syringes and multidose pens from concept through commercialization Develop device and combination product requirements including user and stakeholder needs technical requirements and ensure appropriate engineering translation subsequent verification validation of requirements Oversee human factors usability engineering efforts ensuring compliance with FDA guidance IEC 62366 Facilitate design transfer to manufacturing ensuring smooth transition scalability Collaborate cross-functionally with clinical regulatory commercial supply chain other key functions to ensure integration of device development activities Author relevant portions of regulatory submissions INDs IMPDs NDAs BLAs etc for devices combination product programs Manage collaborate with vendors CDMD test vendors consultants integrate deliverables into project Design History File Ensure product development aligns with relevant standards ISO ISO11040 ASTM D4169 ISO14971 IEC 62366
Responsibilities
- Lead the design and development of combination products including autoinjectors pre-filled syringes and multidose pens from concept through commercialization.
- Develop device and combination product requirements including user stakeholder needs technical requirements secure appropriate engineering translation subsequent verification validation if required.
Job description
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